Prevention and Treatment of CINV Caused by TC Regimen in Gynecological Malignant Tumor Patients

NCT06007586 | Completed Phase 3

• 1 other identifier: CINV202306
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 2

Brief Summary

To determine the best method to prevent CINV caused by TC regimen in patients with gynecological malignant tumor. Paclitaxel-carboplatin (TC) is the most widely used regimen for gynecologic malignancies, yet chemotherapy-induced nausea and vomiting (CINV) remain common and distressing. Optimal prophylaxis is uncertain. This trial evaluated whether adding the NK1 receptor antagonist aprepitant to standard two-drug prophylaxis (5-HT3 receptor antagonist plus dexamethasone) improves CINV control.

Conditions

Fallopian Tube Cancer; Gynecological Tumor; Ovarian Cancer; Cervical Cancer; Endometrial Cancer

Keywords

Gynecologic Cancer; chemotherapy-induced nausea and vomiting; Paclitaxel-carboplatin

Outcome Measures

Primary Outcomes (1)

• Complete response (CR) rate in the delayed period

  CR is defined as no emesis, no significant nausea (VAS ≤4, where 0 = none, 10= = most severe), and no use of rescue antiemetics.

  24 hours to 7days after chemotherapy (each cycle is 21 days)

Secondary Outcomes (5)

• CR rates in the acute phase (0-24 hours) and overall phase (0-7 days).

  acute phase: within 24 hours after chemotherapy (each cycle is 21 days); overall phase: within 7 days after chemotherapy (each cycle is 21 days).

• the use of rescue antiemetic

  within 7 days after chemotherapy (each cycle is 21 days).

• patient satisfaction

  On day 7 and 14 of each cycle (each cycle is 21 days).

• AEs

  within 7 days after chemotherapy (each cycle is 21 days).

• severity of nausea

  within 7 days after chemotherapy (each cycle is 21 days).

Study Arms (2)

Group A

EXPERIMENTAL

patients in group A received the two-drug antiemetic regimen (placebo cycle) during the first cycle followed by the three-drug regimen (aprepitant cycle) during the second cycle. The two-drug regimen (placebo cycle) consisted of intravenous placebo 130 mg, intravenous ondansetron 8 mg, and intravenous dexamethasone 12 mg, all administered 30 minutes before chemotherapy on day 1, followed by oral dexamethasone 8 mg once daily on days 2-4. The three-drug regimen (aprepitant cycle) replaced placebo with intravenous aprepitant 130 mg on day 1, with all other medications administered as in the two-drug regime

Drug: Aprepitant Injection

Group B

EXPERIMENTAL

patients in group B received the regimens in the reverse order. The three-drug regimen (aprepitant cycle) replaced placebo with intravenous aprepitant 130 mg on day 1, with all other medications administered as in the two-drug regime. The two-drug regimen (placebo cycle) consisted of intravenous placebo 130 mg, intravenous ondansetron 8 mg, and intravenous dexamethasone 12 mg, all administered 30 minutes before chemotherapy on day 1, followed by oral dexamethasone 8 mg once daily on days 2-4.

Drug: Aprepitant Injection

Interventions

Aprepitant Injection DRUG

Two antiemetic groups use placebo, dexamethasone and ondansetron. Three antiemetic groups use aprepitant, dexamethasone and ondansetron.

Also known as: dexamethasone, ondansetron

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• the Norman Bethune's "Research Wing Promotion"-Supporting Research Projects: collaborator
• Peking Union Medical College Hospital Talent Cultivation Program: collaborator
• Qilu Pharmaceutical Co., Ltd.: collaborator
• Medical High Level Talents Program: collaborator
• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (2)

Dengfeng Wang

Chengdu, Sichua, 610041, China

Location

Sichuan Cancer Hospital

Chengdu, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Fallopian Tube Neoplasms; Vomiting

Interventions

Aprepitant; Dexamethasone; Ondansetron

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Fallopian Tube Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Both patients and investigators, including follow-up staff, were blinded to treatment allocation.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 23, 2023
• Study Start: May 31, 2024
• Primary Completion: June 20, 2025
• Study Completion: July 4, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)